Novel Coronavirus Infection and Reproductive Function

January 13, 2023 updated by: Bing Yao, Jinling Hospital, China

The Effects and Underlying Mechanisms of Novel Coronavirus Infection on Reproductive Function and Assisted Pregnancy Outcome

This study aims to observe the impact of COVID-19 infection on the reproductive function and assisted pregnancy outcome of infertile couples undergoing assisted reproductive technology and to determine which factors are related to the clinical pregnancy rate. A multicenter, prospective, observational cohort study was adopted. Infertile couples who met the selection criteria were included in this study, the SAS anxiety self-rating scale was filled out, the basic situation was observed, and blood samples and related tissues were collected for testing. Relevant reproductive function, laboratory, clinical, and psychological indicators were collected, and the correlation between the above indicators and the outcome of the ART-related pregnancy were analyzed.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In this multicenter, prospective, observational cohort study, we included infertile couples based on inclusion criteria. The couples were asked to fill in the SAS anxiety self-rating scale. Basic information about patients' vaccination status, symptoms related to viral infection, menstruation, sexual desire, and sexual function were obtained. Blood samples of couples were collected on the date of diagnosis, the start date of the fresh cycle during assisted reproductive technology treatment, the day of oocyte retrieval, the day of embryo transfer, the day of 14 days, 35 days after embryo transfer, and the day of 70 days of gestation. Follicular fluid, granulosa cells on the day of oocyte retrieval, and embryo culture fluid on the day of embryo transfer were collected. Blood samples and endometrial tissues were collected five days after oocyte retrieval. Blood samples from the menstrual period, endometrial transformation day, and embryo transfer day of the frozen embryo transfer cycle were also collected. Then C-reactive protein, erythrocyte sedimentation rate, procalcitonin and IL-6, granulocyte-macrophage colony-stimulating factor (GM-CSF), TNF-α, VEGF, and other cytokines and chemokines were determined. In addition, fasting blood glucose, insulin, blood lipids, alpha-function, renin-angiotensinase, I-aldosterone, and other susceptibility indicators to COVID-19 infection were tested. Oxygen saturation, malondialdehyde (MDA), HO-1, and SOD oxidative stress indices of the fingertip pulse were determined. An endometrial receptivity gene chip and proteomics detected endometrial tissue. A panel kit for blood vessel and inflammation indicators detected the abortion decidua tissue. Reproductive function indices AMH, INHB, sex hormones, follicle retrieval rate, Gn days, total Gn, endometrial thickness, the incidence of OHSS, semen quality, oocyte maturation rate, fertilization rate, qualified embryo rate, blastocyst formation rate, and other laboratory indices of both men and women were collected. Assisted pregnancy outcome: clinical pregnancy rate, embryo implantation rate, early abortion rate, ongoing pregnancy rate, and other clinical indicators, as well as psychological indicators such as the SAS anxiety scale, were analyzed to determine the correlation between the above indicators and ART-related pregnancy outcome.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Department for Reproductive Medicine, Jinling Hospital
      • Nantong, Jiangsu, China
        • Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital
      • Xuzhou, Jiangsu, China
        • Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Failure to establish a clinical pregnancy after 12 months of regular unprotected intercourse, or due to impaired fertility of the individual or his or her partner, is termed infertility.

Description

Inclusion Criteria:

  • Diagnosed with infertility

Exclusion Criteria:

  • Patients with contraindications to pregnancy or assisted reproductive technology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infertile couples infected or not infected with COVID-19
Infertile couples infected or not infected with COVID-19 were included.This is an observational study with no interventions.
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy rate
Time Frame: 1 year
If the fetal sac, fetal bud, and primitive fetal heartbeat are found by vaginal B-ultrasound examination 55-65 days after embryo transfer, the diagnosis of ongoing pregnancy will be made.A
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical and laboratory indicators related to male and female reproductive function
Time Frame: 1 year
AMH, INB, sex hormone, follicle output rate, Gn days, total Gn, endometrial thickness on the embryo transfer day, semen quality; Oocyte maturation rate, fertilization rate, high-level embryo rate, blastocyst formation rate
1 year
Outcome indicators of assisted pregnancy
Time Frame: 1 year
Embryo implantation rate, early abortion rate, ongoing pregnancy rate, incidence of OHSS
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coagulation index
Time Frame: 1 year
D-dimer
1 year
Indicators of susceptibility to COVID-19 infection
Time Frame: 1 year
blood lipid, blood sugar, insulinand thyroid function
1 year
Oxidative stress index
Time Frame: 1 year
fingertip pulse oxygen saturation
1 year
SAS Anxiety Scale
Time Frame: 1 year
SAS Anxiety Scale
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Investigators

  • Study Chair: Bing Yao, PHD, Department of Reproductive Medicine, Jinling Hospital
  • Study Director: Li Chen, PHD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Xiaojie Huang, PHD, Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital
  • Principal Investigator: Jiayi Ding, PHD, Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital
  • Principal Investigator: Qin Sun, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Meiling Li, PHD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Cheng Zhou, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Xi Chen, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Yuming Feng, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Juanjuan Xu, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Haiyan Fu, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Cencen Wang, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Hong Zhang, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Lu Zheng, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Yuxiu Liu, PHD, Department of Critical Care Medicine, Jinling Hospital
  • Principal Investigator: Xiaofang Tan, MD, Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital
  • Principal Investigator: Yunxia Zhu, MD, Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital
  • Principal Investigator: Jueraitetibaike Kadiliya, PHD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Zhichan Zou, MD, Department of Reproductive Medicine, Jinling Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 20, 2023

Primary Completion (Anticipated)

January 31, 2024

Study Completion (Anticipated)

January 31, 2024

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 13, 2023

First Posted (Estimate)

January 16, 2023

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-19 and reproduction

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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